Back to resultsComparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Abacavir sulfate
Nelfinavir mesylate
Lamivudine
GW433908
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are at least 13 years old (consent of parent or guardian needed if under 18). Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children. Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study. Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more. Exclusion Criteria Patients will not be eligible for this study if they: Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study. Have an active/acute CDC Category C event. Are unable to absorb or take medicines by mouth. Are pregnant or breast-feeding. Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient. Have had pancreatitis or hepatitis within the last 6 months. Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study. Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken. Have received an HIV vaccine within 3 months before the study drug will be taken. Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study. Have received experimental treatments. Have allergies which might interfere with the study, in the opinion of the doctor.
Sites / Locations
- Orange County Ctr for Special Immunology
- AIDS Healthcare Foundation
- LAGLC
- Kaiser Hospital
- Park Ctr for Health / Keith Vrhel
- AIDS Research Alliance
- Dupont Circle Physicians Group
- Infectious Disease Consultants
- CRI of South Florida
- Therafirst Med Ctr
- Gary Richmond MD
- Univ of Miami Dept of Medicine
- Specialty Med Care Ctrs of South Florida Inc
- Infectious Diseases Associates
- Jeffrey Levenson
- Infectious Disease Research Inst
- AIDS Research Consortium of Atlanta
- Med College of Georgia
- SMO USA
- Indiana Univ Med School
- Brigham and Women's Hosp
- Hawthorne Med Associates / PAACA
- Abbott-Northwestern Hosp / Clinic 42
- Southampton Healthcare Inc
- VAMC New Jersey Healthcare System
- North Jersey Community Research Initiative
- Bronx Veterans Affairs Med Ctr
- SUNY / Erie County Med Ctr at Buffalo
- North Shore Univ Hosp
- St Lukes - Roosevelt Hosp Ctr
- Univ of Cincinnati / Holmes Hosp
- Milton S Hershey Med Ctr
- Hahnemann Univ Hosp
- Burnside Clinic
- Methodist Healthcare
- Nicholas Bellos
- Joseph C Gathe
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00009061
Brief Title
Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
Official Title
A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2002
Overall Recruitment Status
Unknown status
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Glaxo Wellcome
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.
Detailed Description
Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
624 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
GW433908
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
Are at least 13 years old (consent of parent or guardian needed if under 18).
Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.
Exclusion Criteria
Patients will not be eligible for this study if they:
Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
Have an active/acute CDC Category C event.
Are unable to absorb or take medicines by mouth.
Are pregnant or breast-feeding.
Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
Have had pancreatitis or hepatitis within the last 6 months.
Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
Have received an HIV vaccine within 3 months before the study drug will be taken.
Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
Have received experimental treatments.
Have allergies which might interfere with the study, in the opinion of the doctor.
Facility Information:
Facility Name
Orange County Ctr for Special Immunology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
LAGLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Kaiser Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Park Ctr for Health / Keith Vrhel
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
AIDS Research Alliance
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
Infectious Disease Consultants
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
CRI of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Therafirst Med Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Gary Richmond MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Univ of Miami Dept of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Specialty Med Care Ctrs of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Infectious Diseases Associates
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Jeffrey Levenson
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Infectious Disease Research Inst
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
SMO USA
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30013
Country
United States
Facility Name
Indiana Univ Med School
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hawthorne Med Associates / PAACA
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02745
Country
United States
Facility Name
Abbott-Northwestern Hosp / Clinic 42
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Southampton Healthcare Inc
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
VAMC New Jersey Healthcare System
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032842
Country
United States
Facility Name
Bronx Veterans Affairs Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
North Shore Univ Hosp
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
St Lukes - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Univ of Cincinnati / Holmes Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Hahnemann Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Burnside Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Methodist Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Nicholas Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Joseph C Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
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